Regulatory Affairs Associate Jr - Lake Forest, United States - Spectraforce Technologies

    Spectraforce Technologies
    Spectraforce Technologies Lake Forest, United States

    3 weeks ago

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    Description
    Job Title: Regulatory Affairs Associate Jr

    Duration: 7 months

    Location: Lake Forest, IL 60045

    Responsibilities:
    • Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure
    • Prepares metrics associated with the process for Executive Management Review (EMR) * Completes final signature approval of an ePAS package (i.e., FSG Approval)
    • Data review, analysis, and verification.
    Top 5 skills/requirements -
    • Strong analytical and problem-solving skills.
    • Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
    • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
    • Ability to work with people from various disciplines and cultures.
    • Strong attention to detail.
    • Good organizational / project management skills to manage and track a wide range of tasks; ability to develop realistic action plans as well as prioritizing work activities.
    Preferred Skills:
    • Similar skillset with a more regulatory or quality experience would be beneficial.
    Education:
    • BS in engineering or scientific degree / 1+ years experience in a medical device or similarly regulated industry.